NCT06101511

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,806 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Conditions

• Postoperative Complications
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs	The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial

Timeline

• Start date: 2023-12-11
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2023-10-26
• Last updated: 2025-01-30

Locations

1 site across 1 country: Netherlands